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The Food and Drug Administration (FDA) is responsible for protecting public health by regulating products such as prescription drugs and vaccines and has the authority to investigate alleged criminal activity related to FDA-regulated products, for example on the sale of counterfeit drugs. Within FDA, the Office of Criminal Investigations (OCI) investigates individuals and companies external to FDA. FDA also has the authority to investigate allegations of FDA employee misconduct and these internal investigations are conducted by the Office of Internal Affairs (OIA), a distinct office within OCI. GAO was asked to examine FDA's (1) oversight of OCI investigations, (2) oversight of OIA investigations, and (3) funding, staffing, and workload for OCI. GAO interviewed agency officials, reviewed FDA documents including those describing its investigative policies, and examined FDA data on OCI resources and workload, from fiscal years 1999 to 2008.

Although OCI maintains policies to guide its investigations, FDA's oversight of OCI's investigations of individuals and companies external to FDA is limited. As a key element of FDA's oversight of OCI, FDA's assessment of OCI's six field offices is intended to ensure compliance with investigative policies; however, the assessments are not being implemented in accordance with prescribed time frames. Of the 24 total office assessments that should have been completed by August 2009, only 7, or about 30 percent, were completed and one office had not been assessed in over 10 years. In addition, FDA lacks performance measures that could enhance the agency's oversight by allowing it to assess OCI's overall success. The OCI Director meets weekly with a senior official in the Office of Regulatory Affairs (ORA), the office in which OCI is located, but OCI is not required to report specific information to ORA or other FDA senior-level offices as part of its formal reporting relationship. As a result, FDA depends on OCI's Director to determine what aspects of OCI's investigations should be communicated to FDA senior managers. According to a senior ORA official, OCI operates more autonomously than other offices within ORA, in part, because of OCI's unique role and expertise within FDA. Similar to OCI, OIA has policies in place to guide its internal investigations, but FDA's oversight of OIA's investigations of FDA employees is limited. Although the OIA manager meets periodically with OCI's Director, FDA does not have a requirement for OIA to report specific information to OCI or other FDA senior-level offices on its investigative activities or a process in place to routinely monitor OIA's compliance with its investigative policies. The OIA manager told GAO that the number of investigations is such that he is generally involved in all of them, and can therefore review investigative documents before closing cases to assess compliance with investigative policies. The OIA manager told GAO that his review alleviates the need for a process to monitor compliance with OIA's investigative policies. The potential effectiveness of this review is limited because it relies on the OIA manager, who is also responsible for supervising investigations. FDA's funding and staffing for OCI generally increased annually between fiscal years 1999 and 2008, and OCI's investigative workload also increased over this 10-year period. OCI's funding and staffing include funding and staffing for OIA. OCI's funding, measured by the total funds expended, was about $19 million in fiscal year 1999 and was over $41 million in fiscal year 2008, representing an increase of about 73 percent, when adjusted for inflation. Staffing increased by about 40 percent during this period, from about 165 full-time equivalent employees to over 230. The largest increase in funding and staffing was between fiscal years 2002 and 2003. The OCI Director told GAO that this was the result of funding authorized by the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 to address potential terrorist threats in connection with FDA-regulated products. Investigative workload also increased from fiscal year 1999 to 2008.

Recommendations for Executive Action

Status: Closed - Implemented

Comments: Since our report was issued in 2010 FDA has begun to conduct regular assessments of the Office of Criminal Investigations' (OCI) field offices. In 2012 OCI revised and finalized its policy outlining the OCI office assessment procedures. The policy describes the prescribed time frames for the assessments, the staff members who are responsible for conducting them, documentation requirements, and the process for implementing corrective actions, if needed. According to the policy, FDA will evaluate each OCI field office at least once every three years. In 2013 FDA completed an assessment of OCI's Metro-Washington field office and in 2014 FDA completed an assessment of OCI's New York field office. FDA has begun assessing other OCI field offices and has established a schedule for the remaining OCI field offices.

Recommendation: To ensure OCI's compliance with investigative policies the Secretary of Health and Human Services (HHS) should instruct the Commissioner of FDA to have regular assessments of OCI's field offices conducted in accordance with its existing policy.

Agency Affected: Department of Health and Human Services

Status: Closed - Implemented

Comments: Since our report was issued in 2010 FDA has established a review procedure for the assessment of its Office of Internal Affairs(OIA). In 2012 FDA revised and finalized its procedures for evaluating FDA's Office of Criminal Investigations' (OCI) compliance with its investigative policies and according to FDA officials, these procedures also apply to OIA, which is located within OCI. In 2013 FDA completed an assessment of OIA's compliance with its investigative policies.

Recommendation: To ensure OIA's compliance with investigative policies, the Secretary of HHS should instruct the Commissioner of FDA to establish a review procedure for the assessment of OIA's compliance with its investigative policies.

Agency Affected: Department of Health and Human Services

Status: Closed - Not Implemented

Comments: Since our report was issued in 2010 FDA has continued to use the same measures to track the investigative activities of its Office of Criminal Investigations (OCI). Although FDA has established other measures to track its activities, they are not meaningful performance measures and thus will not allow FDA to assess whether OCI's investigative program is achieving its desired results.

Recommendation: To assess whether OCI's criminal investigative program is achieving its desired results, the Secretary of HHS should instruct the Commissioner of FDA to establish performance measures and assess program results against them.